Steroid eluting stent

In deciding whether to submit a supplement to your approved traditional PMA or to submit a new traditional PMA 5 for a modified device, we recommend you first ascertain whether, and to what extent, you can rely on the preclinical testing and clinical data submitted in your traditional PMA to support the safety and effectiveness of your modified device. If you need to conduct both new preclinical testing and new clinical testing to demonstrate reasonable assurance of safety and effectiveness of the modified device, you should assume that this is a new device that will require a submission of a new traditional PMA. 6